Author Question: The Tuskegee study was ethically objectionable because informed consent was flawed, an available ... (Read 35 times)

acc299 · **on:** Jul 8, 2018

The Tuskegee study was ethically objectionable because informed consent was flawed, an available treatment was not provided, and deception was practiced.

If informed consent had been properly administered and research subjects informed of the availability of penicillin when it became available, why would this still represent an ethically objectionable study? (Select all that apply.)
a. The researcher has an obligation to actively do good for the research subjects; merely informing them of the availability of penicillin would not have been sufficient to meet this obligation.
b. It took place in one state of the Union and so had limited generalizability.
c. Some of the research subjects were illiterate and could not provide consent.
d. There was no need for the study to be performed in the first place, since enough was known about syphilis at the time.
e. Since African American men in Alabama were in an inferior social position, they constituted an underrepresented and potentially vulnerable population; every effort should have been made to include participants from other ethnic groups.

Question 2

A researcher obtains consent from a person with a recent traumatic brain injury (TBI) to observe the person and test her at intervals, using cognitive survey instruments.

The person has not yet regained the ability to speak, and can understand and obey only simple commands. She nods yes, and shakes her head for no. The subject's husband, who has the authority to consent for his wife because he has legal power of attorney for health care, is consented for the study, and the patient is asked to assent.. Does this fulfill the requirements for consenting someone with diminished capabilities? Why or why not? (Select all that apply.)
a. Yes, it does.
b. No, it does not.
c. The subject should have been told the purpose of the study over and over again, and the tests the researcher planned to administer, until the subject nodded that she understood. Her husband should not make this decision for her.
d. The researcher must obtain consent from both the legal representative and the subject.
e. The researcher need not obtain assent for research involving persons with decreased ability or total inability to give informed consent. The subject will probably not remember any of this later, anyhow.
f. The subject should have been asked to consent, and the husband to assent. That is the proper procedure.
g. The prospective subject can understand only simple commands but, because of her TBI, she is not competent to consent.
h. The subject is asked to assent in case she has an opinion about this and might understand the purpose of the study. Eliciting her cooperation is wise in either case.

JYan · **Reply #1 on:** Jul 8, 2018

Answer to Question 1

ANS: A, E
In 1932, the U.S. Public Health Service (U.S. PHS) initiated a study of syphilis in black men in the small rural town of Tuskegee, Alabama. The study, which continued for 40 years, was conducted to determine the natural course of syphilis in the adult black male. The research subjects were organized into two groups: one group consisted of 400 men who had untreated syphilis and the other consisted of a control group of 200 men without syphilis. Many of the subjects who consented to participate in the study were not informed about the purpose and procedures of the research. Some individuals were unaware that they were subjects in a study. The subjects were examined periodically but were not treated for syphilis, even after penicillin was determined to be an effective treatment for the disease in the 1940s. There was insufficient knowledge about the natural course of syphilis at the time the study was begun. Consent of illiterate subjects does not prohibit consent. Single-site research is not considered ethically objectionable per se.

Answer to Question 2

ANS: A, G, H
Some persons have diminished autonomy or are vulnerable and less advantaged because of legal or mental incompetence, terminal illness, or confinement to an institution (Fry et al., 2011). These persons require additional protection of their right to self-determination, because they have a decreased ability, or an inability, to give informed consent. In addition, these persons are vulnerable to coercion and deception. Neonates and children (minors), the mentally impaired, and unconscious patients are legally or mentally incompetent to give informed consent. They should, however, be asked to assent, since their cooperation is essential for high-quality data collection. If an individual is judged incompetent and incapable of consent, the researcher must seek approval from the prospective subject and his or her legally authorized representative.